Tomsk

Researchers are evaluating the long-term safety of study treatments for participants with pulmonary hypertension (PH) who were treated with specific medications in earlier clinical studies and have no other way to access these treatments. This study is designed for people who have finished their previous parent studies and may continue to benefit from the treatment. It is an open-label, phase 3 platform study that follows participants over an extended period to monitor safety. Participants will receive one of the study drugs they used in their parent study, including oral macitentan, selexipag, or a fixed-dose combination of macitentan and tadalafil. Adults take standard doses, while children aged 2 to under 18 years receive doses adjusted for their body weight to match adult exposure levels. Selexipag is given twice daily with dosing adjusted for body weight in children. This treatment continues as in the parent studies, providing ongoing access to these medications. During the study, participants will be regularly monitored for treatment-emergent adverse events, serious adverse events, and any events leading to discontinuation or death, with follow-up lasting up to 84 months. Female participants of childbearing potential will undergo monthly pregnancy testing and agree to contraceptive use during the study and safety follow-up. The study involves ongoing safety assessments to ensure participant well-being while providing access to the study treatments over the long term.

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are conducting a national, multicenter, prospective study in the Russian Federation to collect real-world data on patients with aggressive, advanced endometrial cancer (stages III-IV). The study aims to understand the prevalence of molecular markers such as POLE mutations, dMMR/pMMR, p53 abnormalities, HER2, and PD-L1, as well as to observe first-line postoperative treatment approaches in these patients. Approximately 500 female patients with newly diagnosed aggressive subtypes of advanced endometrial cancer will be enrolled across about 30 sites. The study involves two visits aligned with routine clinical practice. At the first visit, demographic and clinical information will be collected from medical records or patient interviews, along with biopsy or archival tumor samples for molecular testing using immunohistochemistry and genetic sequencing methods. The second visit occurs six months after baseline or at disease progression, whichever is earlier, to gather follow-up data on treatments and disease status. No additional procedures beyond standard care are applied. Participants' data will be securely entered into electronic case report forms by study physicians. Researchers will monitor the rates of molecular markers such as POLE mutation positivity, mismatch repair status, p53 abnormalities, PD-L1 expression, and HER2 expression over 24 months. The overall study duration, from first patient enrollment to final data analysis, is expected to be about 27 months or until all data from 500 patients are collected, including follow-up information.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

This research aims to understand the clinical and demographic characteristics of adult patients living with Neurofibromatosis type 1 (NF1) in Russia. It is an open-label, single-arm, non-interventional, multi-center cohort study focused on evaluating clinical outcomes and patient-reported experiences in routine care settings. The study includes adults diagnosed with NF1 who have plexiform neurofibromas (PN) confirmed by clinical or imaging methods and who experience symptoms related to PN. The study does not involve any investigational treatments or interventions but observes patients during their routine care. It enrolls adults aged 18 years or older with newly diagnosed PN or established PN who have not been treated with MEK inhibitors for PN. Diagnosis confirmation includes clinical assessment, ultrasound imaging, MRI, or biopsy. Patients with certain cancers requiring chemotherapy or radiation, or those who have recently used MEK inhibitors, are excluded. Participants will undergo a variety of assessments at the start of the study, including measurement of age, body metrics, educational background, NF1 complications, and symptoms related to PN. Researchers will review medical histories, hospitalizations, disability status, and prior examinations. The study collects data on PN volume and duration of symptoms and diagnosis. Follow-up visits and further evaluations will be conducted as per routine care. The study monitors changes in disability and overall health status during participation.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.

Researchers are evaluating the effectiveness and safety of two treatments for chronic anal fissure, a painful condition involving a long-lasting tear in the anal canal mucosa resistant to non-surgical care. This condition mainly affects younger and working-age adults and is caused by spasms of the internal anal sphincter. The study compares botulinum toxin injections with lateral subcutaneous sphincterotomy, a surgical method, to determine the best approach for reducing symptoms and complications. The study involves two treatment groups. One group receives a sparing surgical removal of the fissure without cutting the internal sphincter, followed by injections of Botulinum Toxin Type A into specific points of the internal anal sphincter. The other group undergoes lateral subcutaneous sphincterotomy, where the internal sphincter muscle is partially cut to relieve spasm, performed under spinal anesthesia. Both treatments aim to alleviate sphincter spasm but differ in invasiveness and procedure details. Participants will be closely monitored for anal sphincter insufficiency up to 60 days after treatment, focusing on symptoms like incontinence. Assessments include clinical evaluations of sphincter function and safety monitoring for any adverse effects. The study aims to find a treatment that lowers the risk of post-operative incontinence while effectively treating chronic anal fissure, with total participation duration covering the treatment and follow-up period.

Heart failure (HF) is a common condition that worsens with age and leads to increased mortality, hospitalizations, and reduced quality of life. This research compares two types of cardiac resynchronization therapy (CRT) in patients with chronic HF and reduced left ventricular ejection fraction (LVEF): conventional biventricular CRT and left bundle branch pacing (LBBP). While conventional CRT helps about 70% of patients, LBBP is a newer method that may improve heart function by stimulating the heart's left bundle branch directly, potentially reducing the number of patients who do not respond to standard CRT. Participants will receive either a cardioverter-defibrillator with biventricular pacing or one with left bundle branch pacing. Both procedures involve implanting leads through the veins to specific heart areas under local anesthesia, connecting them to a CRT device placed under the skin or muscle. The device is programmed to provide either biventricular or left bundle branch pacing depending on the group. The study aims to evaluate how these two methods affect heart remodeling and clinical outcomes over time. During the study, participants will be closely monitored for clinical changes, including heart function and any hospitalizations due to worsening heart failure. Researchers will assess outcomes such as all-cause mortality and heart failure-related hospital admissions over 24 months. Various tests, including imaging and laboratory evaluations, will be performed to track heart remodeling and function. Safety and effectiveness data will be collected to understand the benefits and potential risks of each pacing method in treating chronic heart failure.